ClinicalTrials.gg
CompletedNCT05632237Updated Apr 20, 2025

Evaluation of a Family Strengthening Program Evaluation in Sierra Leone to Prevent Family Separation

An interventional study of Family strengthening program in Parent-Child Relations, Emotion Regulation and Economic Problems, sponsored by Boston College. Completed at 1 site in Sierra Leone. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by Boston College · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
226
Allocation
Non-randomized
Ages
9 Years and older
Sex
All
01

Study summary

In Sierra Leone, poverty and challenges with family functioning can lead to family separation, and children may go to live on the street or enter residential care institutions/orphanages. Helping Children Worldwide (HCW), a non-profit organization with over 20 years of experience in Sierra Leone, has developed a two-part Family Strengthening Program delivered by their program partners in Sierra Leone, the Child Reintegration Centre, to improve families financial literacy and attachment between caregivers and children, with the ultimate goal of preventing family separation. The hypothesis of this study is that the Family Strengthening Program program is effective at (1) changing parenting behaviors, (2) improving emotional regulation, (3) improving caregiver-child attachment, and (4) improving financial literacy in dyads consisting of children ages 9-13 and their caregivers.

02

Conditions studied

  • Parent-Child Relations
  • Emotion Regulation
  • Economic Problems
  • Parenting

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03

In context

Emotional Regulation

545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.

This study's enrollment of 226 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.

Browse Emotional Regulation studies →

Lead sponsor

Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Dyads must consist of a principal child (the one whose situation initiated their involvement with the Child Reintegration Centre) and their primary caregiver (as defined by the Child Reintegration Centre as the person in the family primarily responsible for the health and wellbeing of the principal child and is noted as such in their case file)
  2. Primary child is ages 9-13
  3. Dyad is actively participating in Child Reintegration Centre services (i.e., child must have been seen by the case manager in the last month)
  4. Dyad lives in the Bo area.

Exclusion criteria

Exclusion criterion:

(1) Family has been assessed by the Child Reintegration Centre to be in active crisis, i.e., specific concerns about the child being at-risk or unsafe (suspicions of abuse or neglect).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
226 participants (actual)

Study arms

  • Experimental
    Family strengthening program

    Behavioral: Family strengthening program

  • No intervention
    Care as usual

    These participants have already been receiving case management from the Child Reintegration Centre prior to the study, and they will continue to receive care as usual, which is to receive normal case management visits without this added Family Strengthening Program component. Case management consists of a social work staff alternating between visiting children at home or at school each month to provide supervision, coaching, counseling, assessments, and identification of additional support needs.

Interventions

  • BehavioralFamily strengthening program

    Phase I: 2-day Family Strengthening Workshop. The specific topics included in the workshop include: emotions, Body Progressive Muscle Relaxation, body stretch, self care, apologizing, routines to promote attachment, teamwork, saving, delayed gratification, anticipating unexpected expenses, identifying family strengths and values. Phase II: Case management with family strengthening curriculum. Curriculum is delivered over the course of four visits (about 3 months), some of which involve both caregiver and child while others are just for the caregiver. Topics included are using appropriate discipline, effective communication for family problem-solving, and home budgeting.

06

What researchers measure

Primary outcomes

  1. Caregiver and child change in emotional regulation as measured by the Difficulties in Emotional Regulation (DERS) scale

    Time frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  2. Change in child attachment as measured by the Inventory of Parent and Peer Attachment (IPPA)

    Time frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  3. Change in caregiver- and child-reported use of punishment by caregiver

    Measures developed for this study tailored for context; e.g., flogging child with hand or cane, public shaming, withholding food

    Time frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

  4. Change in self-reported economic well-being

    Measures developed for this study tailored for context and intervention content; e.g., awareness of income/spending, saving and budgeting behaviors, ability to pay for unexpected expense

    Time frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

Secondary outcomes

  1. Change in child- and caregiver-reported parenting behaviors by caregiver

    Measures developed for this study tailored for context and intervention content; e.g., asking child about their life, spending one-on-one time with child, physically showing affection, giving compliments/praise, using a routine, apologizing, providing emotional support

    Time frame: Baseline: Up to 2 months before intervention; Endline: Up to 2 months after intervention

07

Study locations

1 site
  • the Child Reintegration Centre
    Bo, Sierra Leone
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in May 2023, 7 months.

Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 7 months is below that.

Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2022
First posted
Nov 30, 2022
StartActual
Oct 16, 2022
Primary completionActual
May 22, 2023
CompletionActual
May 22, 2023
Last update
Apr 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05632237
Lead sponsor
Boston College
Collaborators
Christian Alliance for Orphans, Helping Children Worldwide, Child Reintegration Centre
Responsible party
Sarah Neville (PhD, Boston College) — Principal investigator
First posted
Nov 30, 2022
Start date
Oct 16, 2022
Primary completion
May 22, 2023
Completion
May 22, 2023
Last update
Apr 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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